BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL GLENOSPHERE IMPACTOR HEAD

    MDR report key: 1872319 · Received October 12, 2010

    Report

    Report Number
    1822565-2010-00867
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE GLENOSPHERE IMPACTOR HEAD IS FRACTURED. BASED UPON THE LOT NUMBER, THE DEVICE HAD A POTENTIAL FIELD AGE OF BETWEEN 3 AND 4 AGES AT THE TIME OF FAILURE. IT IS POSSIBLE THAT THE FRACTURE WAS DUE TO EXCESSIVE IMPACTION FORCE, BUT WITHOUT FURTHER INFORMATION THIS CANNOT BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON IMPACTION OF THE 40MM GLENOSPHERE, THE SURGEON HEARD A CRACK AND THE BLACK IMPACTION HEAD FELL OFF THE IMPACTOR HANDLE INTO THE WOUND. THE HANDLE WAS INSPECTED AND THERE WERE NO VISIBLE CRACKS OR DEFORMITIES OF THE INSTRUMENT. HOWEVER, A PIECE OF PLASTIC HAD BROKEN OFF OF THE IMPACTOR HEAD AND HAD FALLEN INTO THE WOUND. THE SURGEON RETRIEVED THE PIECE OF PLASTIC FROM THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL GLENOSPHERE IMPACTOR HEAD SHOULDER INSTRUMENT HWA ZIMMER, INC. 60684783

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR